510(k) K213861
K213861 is an FDA 510(k) premarket notification submitted by Cardiocalm Srl for the device "CER-S". The FDA issued a decision of Substantially Equivalent on April 25, 2022. The device falls under product code DQK (Computer, Diagnostic, Programmable), a Class II device regulated under 21 CFR 870.1425. Cardiocalm Srl has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 25, 2022
- Date Received
- December 10, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Computer, Diagnostic, Programmable
- Device Class
- Class II
- Regulation Number
- 870.1425
- Review Panel
- CV
- Submission Type